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The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in large artery elasticity (LAE | Large artery elasticity is measured using a tonometer placed on the forearm. | baseline, Months 1, 4, 8, 12, annually thereafter |
| Change from baseline in small artery elasticity (SAE) | Small artery elasticity is measured using a tonometer placed on the forearm. | baseline, Months 1, 4, 8, 12, annually thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma markers of thrombosis and fibrinolysis | Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future. | baseline, months 4, 8, 12, annually thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
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| Name | Affiliation | Role |
|---|---|---|
| Jason V Baker, MD | University of Minnesota | Study Chair |
| Daniel Duprez, MD, PhD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25711329 | Derived | Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 1):109-18. doi: 10.1111/hiv.12239. |
| Label | URL |
|---|---|
| INSIGHT network website, including information on the START Arterial Elasticity Substudy | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Citrated plasma is collected at each study visit and stored at a central lab for future assessment of changes in plasma markers of thrombosis and fibrinolysis.